Class II — Strata Skin Sciences, Inc.
| Recalling firm | STRATA Skin Sciences, INC. |
|---|---|
| Registered facility | Strata Skin Sciences, inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing. |
| Product | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma. |
| Quantity | US - 1000 , Foreign - 612 |
| Distribution | USA (nationwide) Distribution |
| Initiated | 2017-01-23 |
| Classified | 2017-03-27 |
| Terminated | 2017-06-05 |
| Recall number | Z-1455-2017 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Strata Skin Sciences, Inc. (Z-1455-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76697/
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